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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceTack Endovascular System (4F, 1.5-4.5mm)
Generic Namescaffold, dissection repair
Applicant
Intact Vascular, Inc.
1285 drummers lane, #200
wayne, PA 19087
PMA NumberP190027
Date Received10/01/2019
Decision Date04/10/2020
Product Code QCT 
Docket Number 20M-1286
Notice Date 04/14/2020
Advisory Committee Cardiovascular
Clinical Trials NCT02942966
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use in mid/distal popliteal, tibial and peroneal arteries, ranging in diameter from 1.5 mm to 4.5 mm, for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  
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